The Regulatory Process for Imaging Agents and Devices

This chapter will provide an overview of the process to obtain regulatory approval for molecular imaging agents (probes) and devices for clinical research use. Regulatory approval involves both the university and the US Food and Drug Administration (FDA). There is an infrastructure in place to assure compliance with all rules and regulations. As has been shown in the various chapters in this book, molecular imaging techniques allow for identification of important molecular pathways and biologic processes in both healthy and disease states. Molecular imaging techniques are used to individualize and personalize treatments based on a “molecular phenotype” of the disease at the time of diagnosis and throughout the course of therapy. Being knowledgeable regarding regulatory requirements will assist in obtaining appropriate molecular imaging approvals and detail the required reporting for the studies.